BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
FDA premarket approval P000022/S002 · decided 2001-03-15
Approval details
- PMA number
- P000022
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2000-11-16
- Decision date
- 2001-03-15
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE POSTAPPROVAL STUDY PROTOCOL FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM.
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